Exploratory/Developmental Research Grant Program

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Exploratory/Developmental Research Grant Program

• The R21 Mechanism

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Your guide through the R21 jungle

• Patricia Parmelee, PhD
• (Pat to you)

jun gle, n. a confused or disordered mass
of objects something that baffles or frustrates
by its tangled or complex character a place of
ruthless struggle for survival Merriam-Webster
Online Dictionary http//merriam-webster.com/dicti
onary/jungle
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Your guide through the R21 jungle

• Patricia Parmelee, PhD
• (Pat to you)
• Qualifications
• Years years years reviewing R21s on various
  NIH study sections
• Previously PI on an R21 (AG026121)
• Several R21 applications in various stages of
  development/revision

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Whats an R21?

• According to US DHHS PA-06-181,
• A grant mechanism that is
• intended to encourage exploratory and
  developmental research projects by providing
  support for the early and conceptual stages of
  these projects.

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Whats an R21?

• Explores
• Novel concepts or methods
• Previously un- or understudied issues
• Feasibility/applicability of a research idea
• Develops
• New techniques and approaches
• New models, methods or applications

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R21 applications the basics

• Two years funding
• Up to 275,000 TDC
• Maximum 200,000 in a given year
• Modular budget
• 7-page limit for research plan
• Adobe e-submission
• One revision permitted
• Due Feb. 16 - June 16 - Oct. 16

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Who supports R21s?

• Just about all NIH branches

• NCCAM
• NEI
• NHLBI
• NHGRI
• NLM
• NIA
• NIAAA
• But not FIC, NCI,
  NCMHD, NCRR NIGMS

• NIAID
• NIAMS
• NIBIB
• NICHD
• NIDCD
• NIDA

• NIDCR
• NIDDK
• NIEHS
• NIMH
• NINDS
• NINR

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Characteristics of a successful R21

• By using the R21 mechanism, the NIH seeks to
  foster the introduction of novel scientific
  ideas, model systems, tools, agents, targets and
  technologies that have the potential to
  substantially advance biomedical science.
• US DHHS PA-06-181

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Characteristics of a successful R21

• Innovative
• High risk
• Innovative
• Potentially big pay-off
• Innovative
• Rigorous
• Did I mention innovative?

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Some examples of successful R21s

• Developing materials and methods for a
  translational intervention
• Using existing large data sets to develop
  statistical techniques for modeling change in
  health status
• Finding genes for alcohol-related behaviors
  risk for alcoholism
• Improving the trauma system response to disaster

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What isnt an R21?

• A mini R01
• A maxi R03
• A training grant

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Preparing an R21

• Some frequently asked questions about R21s
• Does the research plan follow the same format as
  an R01?
• Do I need pilot data?
• Do I need to have clear, testable hypotheses?
• The answer? It depends!

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Preparing an R21

• Some frequently asked questions about R21s
• Does the research plan follow the same format as
  an R01?

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Preparing an R21

• Some frequently asked questions about R21s
• Does the research plan follow the same format as
  an R01?
• Do I need pilot data?

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Preparing an R21

• Some frequently asked questions about R21s
• Does the research plan follow the same format as
  an R01?
• Do I need pilot data?
• Do I need to have clear, testable hypotheses?

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Preparing an R21

• Points to ponder as you write
• What truly new knowledge might this yield?
• Whats unique about how Im going about
  generating that knowledge?
• How will this work prepare me to conduct similar,
  larger-scale research?
• Do I have a clear game plan for next steps once
  the R21 is completed?

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Preparing an R21

• Some common errors in writing R21 applications
• Not conveying how the work is exploratory/developm
  ental
• Trying to do too much
• Too much structure (the mini R01)
• Too little structure (trust me)

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How do reviewers ideally view R21s?

• reviewers will focus their evaluation on
• the conceptual framework
• the level of innovation, and
• the potential to significantly advance our
  knowledge or understanding.
• Reviewers will place less emphasis on
  methodological details and certain indicators
  traditionally used in evaluation the scientific
  merit of R01 applications, including supportive
  preliminary data.
• US DHHS PA-06-181

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How do reviewers actually view R21s?

• Sometimes appropriately
• Excellent first step for new investigators with
  a clear long-range research plan
• Good for forays into less well-studied areas
• Sometimes not
• Not accepting exploratory nature
• Holding to R01-level methodological standard
• Unfamiliar with the research area

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Dealing with an overly zealous reviewer

• Be respectful
• We appreciate your thorough critique
• The reviewers correctly pointed out
• but stand your ground
• is not feasible at this first, exploratory
  stage
• Inherent limitations of the R21 mechanism
  preclude
• This study addresses feasibility, not
  hypothesis-testing.
• but will certainly be included in our future,
  full-scale intervention efforts.

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In summary.

• R21 is a great foot in the door
• Not always well understood by investigators OR
  study section!
• Work closely w program officer to determine if
  its appropriate for your research